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NCT Number: NCT04407780

Cardio-Oncology Registry

Cardio-oncology is an emerging field. Most of the data available have been issued from either retrospective analysis, industry data or pharmacovigilance data. These data sources include a number of bias.

CONFUCIUS is a single tertiary centre prospective registry including all patients who have been referred for cardio-oncology assessemnt.

The objectives are to provide a comprehensive vue of cardoi-oncology, enable to detect early signals of cardiotoxicity and enhance ancillary projetcts aiming at specific populations (e.g., type of cancer) and/or drugs.

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Key information

Conditions

Cancer Arrhythmia Arrhythmias, Cardiac Cardiac Disease Cardiovascular Diseases Glucose Metabolism Disorders Heart Diseases Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Neoplasms Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Paris - Centre Université de Paris

Paris, 75015, France

Location status: Recruiting

Location contact

Mariana Mirabel, MD, PhD

CONTACT

[email protected]

+33156095636

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • referred to cardio-oncology

Exclusion criteria

  • refusal to participate

Treatment and study plan

No interventions are planned

Other

Non applicable

Primary outcomes

  1. Incidence of cardio-toxicty

    Time frame: 5 years

    Number of patients with cardiotoxicity in a cohort of patients referred to a cardio-oncology clinic

Secondary outcomes

  1. Analysis of cardiotoxicity

    Time frame: 5 years

    Correlation of cardio-toxicity overall, and in predefined subgroups; statistical associatoin with outcomes.

  2. Analysis of cardioprotective strategies

    Time frame: 5 years

    Correlation between the use of cardiovascular drugs and the number of patients with cardiotoxicity.

  3. Analysis of underlying cardiovacsular profile

    Time frame: 5 years

    Correlation between underlying cardioascular profile and the number of patients with cardiotoxicity.

  4. Analysis of arrhythmias

    Time frame: 5 years

    Correlation between incident arrhythmias and cancer drugs

  5. Precision medicine

    Time frame: 5 years

    Correlation between biomarkers with use of artificial intelligence and the number of patients with cardiotoxicity.

  6. Oncology

    Time frame: 5 years

    Adherence to oncology treatment plan as stated in the multidisciplinary team meeting in patients with cardio-oncology assessment compared to matched patients with no cardio-oncology assessment within our institution; outcomes.

  7. Cardiovascular outcomes

    Time frame: 10 years

    Assess cardiovascular outcomes (cardiovascular death, admission for heart failure, acute coronary syndrome, stroke).

  8. Any advserse event

    Time frame: 5 years

    Correlation between any adverse event, oncology treatment, and outcomes.

  9. Behaviour

    Time frame: 5 years

    Correlation of any behaviour treatment (exercice, rehabilitation, nutrition consultation) and the number of patents with cardiotoxocity.

  10. Metabolic

    Time frame: 5 years

    Correlation between oncology treatments, cardiovascular therapies, behaviour therapies and the number of patients with metabolic disorders (diabetes or dyslipidemia).

Study contacts

Contact information is provided by the study sponsor or research team.

Mariana Mirabel, MD, PhD

CONTACT

[email protected]

+33156095636

Sponsors and collaborators

Lead sponsor

European Georges Pompidou Hospital

Other

Registry information

Official study title

Cardio-Oncologie: étude Pilote évaluant la faisabilité, Utilité Concrète, Interdisciplinaire d'Une Unité Spécialisée

Acronym: CONFUCIUS

Important dates

Study start
2017
Primary completion
2022
Study completion
2027
First posted
May 29, 2020
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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